Allergy is a major cause of illness in the United States, effecting millions of Americans and compromising their daily life. The most current information on the prevalence of food allergy in the U.S. indicates that up to 6% of children and 4% adults of the total population have IgE mediated food allergies. Severe food related allergic reactions result in an estimated 30,000 emergency room visits, 2,000 hospitalizations and 150 deaths annually. Furthermore, clinical data and surveys have observed an increase in the prevalence of allergies, including food allergies, over the years.
The most severe and life threatening adverse reactions to foods are associated with immunoglobulin E (IgE)—mediated hypersensitivity. An allergic reaction occurs due to an abnormal immune system response to specific antigens or proteins present in food. The clinical manifestations of food allergies range from mild irritations to life threatening respiratory distress and shock. Symptoms often occur within a few minutes to hours after consumption of the allergen present in food and generally progresses on a continuum from a mild reaction to a severe reaction.
Currently there are three major approaches being used in the diagnosis of allergies, including: 1) Skin test or skin prick test (SPT), 2) Assays of serum IgE, levels and 3) Histamine release test. The major drawbacks of these tests is that these tests may result in false negative or false positive results, have low sensitivity, and are highly invasive. Additionally, these tests must be administered by trained personnel in controlled environments, which results in a considerable cost increase. The CAP allergy evaluation technology must be administered by trained personnel, thereby incurring substantial costs and take a substantial amount of time before rendering test results. Hence, there is an urgent need to develop reliable assays to detect the onset of food allergies in a rapid, sensitive and less invasive way that does not involve highly trained personnel and expensive equipment, making the assay cost effective.